The present invention relates to a stable isotopic identification and method for identifying products using naturally occurring isotopic concentrations or isotopic ratios in products, especially in the pharmaceutical industry, and more particularly to an identification and a method utilizing such isotopic concentrations or ratios in a machine readable form for identifying products and tracking products through manufacturing, marketing and use of a product, and readily indexing product information to the product.
The stable isotopic composition of matter has been recognized since about 1945 as a criterion for differentiating one material from another with the same elemental composition. In the field of geochemical oil exploration and prospecting, measurement of the isotopic compositions of large numbers of individual organic compounds of oil samples from various oil reservoirs have assisted in clarifying the origin of specific compounds correlating the organic compounds with particular petroleum sources, recognizing the existence of multiple petroleum sources, examining the mechanisms of petroleum generation, and improving the sensitivity of petroleum migration studies. This information, particularly in connection with seismological data, can be used to predict locations of other oil reservoirs to which oil may have migrated from a common source of generation or formation.
Isotope ratio monitoring has further applications in the biomedical field, wherein non-radioactive and stable isotopes are used as tracer labels in drug metabolism and other biomedical studies where natural variations in isotopic abundances may also carry additional information regarding sources and fates of metabolites. Current radioactive and stable isotopic labeling apparatus and methods in the medical fields employ typically costly labeled compounds having isotope ratios much different than those found in natural abundance. Since the inception of these techniques, improvements in isotope ratio monitoring sensitivity and precision, and a reduction in sample size and the required amount of the taggant material have occurred. In some cases, the relative concentration of the minor isotope versus the major isotope of naturally occurring isotopic ratios is so small that monitoring the isotope ratio has been problematic. It is therefore highly desirable to provide a new and improved stable isotopic identification and a method of identifying products utilizing a stable isotopic identification. It is also highly desirable to provide a new and improved stable isotopic identification and a method for identifying products utilizing the same which is fully operational utilizing naturally occurring variations in isotopic abundance, thus eliminating costly taggants in some applications.
In the combustible fuel, environmental, foods, explosive and ammunition and paint industries, the new and improved stable isotope identification can be used.
In the pharmaceutical industry, there is a need to trace ingredients through the manufacturing process, through the marketplace, and into various usages. Products such as active pharmaceutical ingredients (APIs), excipients of drug products, impurities in drug products, raw materials and drug products are included in those products which a pharmaceutical manufacturer may wish to trace. The ready identification of products in the marketplace allows a pharmaceutical manufacturer to monitor its products for quality purposes as well as to act as an impediment against fraudulent “knock-offs” or counterfeits. It is therefore highly desirable to provide a new and improved stable isotopic identification which can be used in the pharmaceutical industry for APIs, drug products, excipients of drug products, and/or impurities of drug products and a new and improved method of identifying and using such an identification. It is also highly desirable to provide a new and improved stable isotopic identification utilizing the intrinsic or ambient variability of the stable isotopic compositions or ratios of the product (not artificially altered or “tagged”) thereby eliminating the need for relatively expensive taggants and the resultant dilution or contamination by impurities of the product, and a method utilizing such isotopic concentrations or ratios in a machine readable form for identifying products, and tracking products through manufacturing, marketing and use of a product, and readily indexing product information to the product.
New techniques for measuring highly precise on-line isotopic ratios are now available. The probability of isotopic compositions of two batches from independent sources being the same is inversely proportional to the product of the dynamic ranges of each type of isotopic analysis undertaken, whether bulk or compound specific analyses. The “dynamic range” is defined herein as the range of values expected for a given type of measurement divided by the 1-sigma standard deviation of that measurement. All products such as APIs, drug products, excipients of drug products and/or impurities of drug products have intrinsic or ambient measurable amounts of stable isotopes of common light elements such as carbon, hydrogen, oxygen, nitrogen, sulfur, and chlorine. It is therefore highly desirable to provide a new and improved stable isotopic identification derived from stable isotopic compositions or ratios of common light elements of the product and a method of identifying the products and indexing product information to the product utilizing the same. It is also highly desirable to provide a new and improved stable isotopic identification for APIs, drug products, excipients of drug products and/or impurities of drug products which can be readily determined by either on-line or off-line analysis of the intrinsic, ambient or naturally occurring stable isotopic compositions or ratios of the common light elements in such products and a method for identifying and tracing such products throughout the manufacturing process, the marketplace and use and potential misuse.
Finally, it is highly desirable to provide a new and improved stable isotopic identification and method for utilizing the same including all of the above features throughout the chemical, petroleum, pharmaceutical, biomedical, food, environmental, paint, explosive-ammunition, and combustible fuel industries.